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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00312377 |
This large phase III clinical study is studying the effect of vandetanib (ZACTIMA) in treating non-small cell lung cancer (NSCLC). Vandetanib is a new type of agent that targets the blood supply to a cancer tumour (through it's anti-VEGFR properties) and the tumour cells themselves (through it's anti-EGFR actions). This study will look at the effects of vandetanib in lung cancer patients who have had their cancer re-appear after treatment with standard chemotherapy.
This clinical study will test if the vandetanib anti-VEGF and anti-EGFR characteristics can deliver longer improved progression free survival and improved overall survival than docetaxel (Taxotere) alone.
All patients participating this clinical study will receive treatment with docetaxel, a commonly used treatment for recurrent non-small cell lung cancer.
In addition, some patients will also receive vandetanib (ZACTIMA), an anti-EGFR / anti-VEGF agent.
Recent clinical research shows that vascular endothelial growth factor receptor (VEGFR) inhibition, when used with standard chemotherapy, can lead to increased survival in advanced non-small cell lung cancer (NSCLC) patients.
Other research shows that epidermal growth factor receptor (EGFR) inhibitors, like erlotinib (Tarceva) can also increase overall non-small cell lung cancer survival by killing tumour cells and stopping them from dividing.
Condition | Intervention | Phase |
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Non-Small Cell Lung Cancer Lung Cancer |
Drug: Docetaxel Drug: Vandetanib |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Randomized, Double-Blinded, Multi-Center, Study to Assess the Efficacy of Docetaxel (TAXOTERE™) in Combination With ZD6474 (ZACTIMA™) Versus Docetaxel (TAXOTERE™) With Placebo in Subjects With Locally Advanced or Metastatic NSCLC |
Estimated Enrollment: | 1240 |
Study Start Date: | March 2006 |
Study Completion Date: | September 2008 |
Arms | Assigned Interventions |
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1: Active Comparator
Docetaxel monotherapy
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Drug: Docetaxel
oral
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2: Experimental
Vandetanib + Docetaxel
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Drug: Docetaxel
oral
Drug: Vandetanib
oral
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Lung cancer patients who answer true to the following statements are eligible to join this clinical study.
Exclusion Criteria:
Lung cancer patients who answer true to the following are NOT eligible to join this clinical study.
If you are unsure of the meaning of the inclusion and exclusion criteria above, please contact the call center number for help.
Study Director: | AstraZeneca Zactima Medical Science Director, MD | AstraZeneca |
Study ID Numbers: | D4200C00032, 6474IL/0032 |
Study First Received: | April 6, 2006 |
Last Updated: | October 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00312377 |
Health Authority: | United States: Food and Drug Administration |
Non-small cell lung cancer NSCLC |
Docetaxel Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Bevacizumab Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |